First-line Treatment of Helicobacter pylori with the Probiotic Lactobacillus casei rhamnosus LCR35 Alone or in Combination with a Levofloxacin-based Sequential Therapy: A Randomized, Placebo-controlled Phase 3 Study - FORECAST

Kepler Universitätsklinikum, Medcampus III, Klinik für Interne 20 个研究点目标入组 440 人开始时间: 2019年4月9日最近更新: 2024年9月2日

适应症

试验速览

暂无简介。

•1. Signed the informed consent form
•2. Men or women between 18 and 70 years
•3. Histologically-proven Helicobacter pylori-associated gastritis prior to screening
•4. Helicobacter pylori colonization confirmed by stool antigen test
•5. BMI between 18.5 and 35, inclusively
•6. Negative anamnesis for current pregnancy or breast-feeding at Screening and Baseline
•7. Women at child-bearing potential are advised to use an effective method of birth control
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 440
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. History of previous Helicobacter pylori eradication, unless deemed to be irrelevant by the principal investigator (i.e. in cases of a long gap between first eradication and current positive H. pylori result, making reinfection the most propable explanation).
•2. Known intolerances or allergies to any of the study drugs
•3. Severe endoscopic manifestation, such as hemorrhagic gastritis and gastric or duodenal ulcers
•4. Barrett’s oesophagus, high-grade dysplasia, or any kind of malignancy in endoscopy
•5. Use of non-steroidal anti-inflammatory drugs (NSAIDS, exept acetylsalicylic acid if daily dose is
•= 100mg per day), antibiotics, pre- or probiotics within 4 weeks prior to enrollment
•6. History of major abdominal surgery in the past (appendectomy excluded)
•7. History of regular excessive alcohol intake (>40g/d for women, >80g/d for men) or drug abuse
•(steroid-abuse included) within the past 12 months
•8. History of lactose intolerance
•9. Any substantial organ impairment including severe or unstable cardiopulmonary, renal, liver,
•endocrine, or neuro-psychiatric disease
•10. History of cancer in the last five years
•11. History of chronic infectious or immune-deficient diseases
•12. Existing or planned pregnancy or breast-feeding
•13. Difficulty to understand the treatment or to report disease symptoms and adverse effects
•14. Participation in another clinical trial and having received another IMP within the last 30 days prior
•to screening

发起方

Kepler Universitätsklinikum, Medcampus III, Klinik für Interne 2